Company Leadership Changes - Samir R. Patel, M.D. has been appointed as Chief Executive Officer of Akari Therapeutics, effective December 16, 2024, after serving as interim CEO since May 2024 [1][2] - Abizer Gaslightwala has been appointed to the Board of Directors, effective December 16, 2024, following the resignation of Michael Grissinger from the Board [1][7] Strategic Focus and Growth - Under Dr. Patel's leadership, the company successfully closed a merger with Peak Bio in November 2024 and is now focusing on streamlining operations and prioritizing its portfolio, particularly its antibody-drug conjugate (ADC) platform [2] - Dr. Patel expressed commitment to building momentum and driving shareholder value in both the near and long term [2] Leadership Background - Dr. Patel has over 20 years of experience in life sciences, including founding SPEC Pharma, LLC, and holding various roles in Medical Affairs at Centocor, Inc. [4] - Abizer Gaslightwala brings over 25 years of experience in the biotechnology and pharmaceutical industry, currently serving as Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, overseeing a portfolio with total annual sales of $1 billion [6][8] Company Overview - Akari Therapeutics is a biotechnology company focused on developing advanced therapies for autoimmune, oncology, and inflammatory diseases, with lead assets including investigational nomacopan and an ADC platform [10][11]

Core Insights - Akari Therapeutics has appointed Torsten Hombeck, Ph.D. as Chief Financial Officer effective December 16, 2024, bringing over 20 years of experience in biotechnology, finance, and M&A transactions [1][2][3] - Dr. Hombeck previously served as CFO of Akari from 2019 to June 2023, where he raised over $50 million, and has a strong background in clinical development and commercial expertise [3][4] - The company is focused on advancing its first-in-class antibody-drug conjugate (ADC) platform and believes there is significant potential to drive shareholder value [3][5] Company Overview - Akari Therapeutics is a biotechnology company developing therapies for autoimmune, oncology, and inflammatory diseases, with lead assets including investigational nomacopan and an ADC platform [5] - Nomacopan is a bispecific recombinant inhibitor targeting complement C5 activation and leukotriene B4 activity, currently undergoing pre-clinical research for geographic atrophy [5]

Financial Performance - The company reported a loss from operations of $2.9 million for the three months ended September 30, 2024, a 17% increase from a loss of $2.5 million in the same period of 2023[176]. - For the nine months ended September 30, 2024, the loss from operations totaled $16.4 million, a 40% increase compared to a loss of $11.7 million for the same period in 2023[176]. - Net loss applicable to ordinary shareholders for the three months ended September 30, 2024, was $2.9 million, and for the nine months ended September 30, 2024, it was $16.0 million, compared to $5.9 million for the same period in 2023[200]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $2.9 million, up 17% from $2.5 million in the same period of 2023[176]. - Research and development expenses increased by approximately $0.5 million, or 146%, for the three months ended September 30, 2024, compared to the same period in 2023[178]. - Total research and development expenses for the nine months ended September 30, 2024, were $5.7 million, a 95% increase from $2.9 million in the same period of 2023[178]. - Personnel costs decreased by $0.5 million, or 60%, for the three months ended September 30, 2024, and by $1.2 million, or 48%, for the nine months ended September 30, 2024, compared to the same periods in 2023, primarily due to the impact of the RIF announced in May 2024[184]. - General and administrative expenses decreased by approximately $1.1 million, or 39%, for the three months ended September 30, 2024, and by approximately $2.2 million, or 25%, for the nine months ended September 30, 2024, compared to the same periods in 2023[187]. - Merger-related costs for the three and nine months ended September 30, 2024, were $1.0 million and $2.3 million, respectively, with no such costs incurred during the corresponding 2023 periods[188]. - Restructuring and other costs for the three and nine months ended September 30, 2024, were $0.1 million and $1.7 million, respectively, including $0.3 million of non-cash share-based compensation expense for the nine months ended September 30, 2024[190]. Cash Position and Funding - As of September 30, 2024, the company had $2.2 million in cash and an accumulated deficit of $243.5 million, with no revenue generated to date[202]. - The company expects existing cash, plus cash from the November 2024 Private Placement, to fund operations into the first quarter of 2025[211]. - In November 2024, the company agreed to sell and issue 1,713,402 ADSs and warrants for aggregate gross proceeds of $3.2 million[207]. - In May 2024, the company raised approximately $7.6 million from a private placement of 4,029,754 ADSs and warrants[208]. - The company may need to raise additional funds and is exploring various financing options, including equity and debt securities[204]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $10,428 thousand, compared to $12,023 thousand for the same period in 2023[219]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $8,834 thousand, an increase from $3,503 thousand in the same period of 2023[221]. - The company reported a net decrease in cash of $1,599 thousand for the nine months ended September 30, 2024, compared to a decrease of $8,519 thousand in 2023[219]. - The company has substantial doubt regarding its ability to continue as a going concern within one year after the issuance of its unaudited condensed consolidated financial statements[217]. - The company is facing challenges in obtaining funding due to market receptivity and integration of operations following a merger[216]. - The company’s cash position may be adversely impacted by increases in expenses or delays in clinical development[216]. Operational Changes - The company implemented a reduction-in-force of approximately 67% of its total workforce as part of an operational restructuring plan[172]. - The HSCT-TMA program was suspended in May 2024 due to a portfolio prioritization review, impacting clinical trial costs[169][172]. - The merger with Peak Bio was completed on November 14, 2024, expanding the company's pipeline with new assets and technologies[173]. Regulatory and Development Plans - The company plans to file an Investigational New Drug Application (IND) with the FDA in 2025 for PAS-nomacopan, a long-acting form of nomacopan[168]. Accounting Policies - The company has not experienced material changes to its critical accounting policies and estimates since December 31, 2023[226]. - The company is a smaller reporting company and is not required to provide certain market risk disclosures[227].

Company Overview - Akari Therapeutics, Plc has completed a merger with Peak Bio, Inc, creating a biotechnology company focused on advancing multiple disease therapies, particularly in Antibody Drug Conjugates (ADCs) and treatments for autoimmune and inflammatory diseases, including Geographic Atrophy (GA) [1][2] Financing Details - The company secured $3.2 million in PIPE financing and obtained a $50 million term sheet for an equity line of credit (ELOC) [1][6] - A definitive agreement for a private placement financing was entered into on November 13, 2024, involving the sale of 1,713,402 unregistered American Depository Shares (ADSs) at a price of $1.70 for most investors and $2.385 for insiders [3] - The warrants associated with this financing have a term of 3 years and an exercise price of $2.26 per ADS [3] Strategic Focus - The company plans to execute its strategy with a specific focus on ADC and GA milestones over the next 12 months, leveraging immediate capital from PIPE financing and the ELOC [2] - The incoming Chairman, Hoyoung Huh, emphasized the goal of driving shareholder value and seeking new opportunities in oncology, autoimmune, and inflammatory diseases [2] Future Outlook - The private placement is expected to close shortly after the merger, subject to customary closing obligations [4] - The ELOC allows the company to sell up to $50 million of newly issued ADSs over a 3-year period, providing flexibility in funding based on market conditions and company operations [6][7] Company Background - Akari Therapeutics is developing advanced therapies for autoimmune and inflammatory diseases, with its lead asset being investigational nomacopan, a bispecific recombinant inhibitor targeting complement C5 activation and leukotriene B4 activity [8]

BOSTON and LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an innovative biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, announces shareholder approval in connection with the merger of Akari Therapeutics, Plc (the Company) and Peak Bio, Inc. At a General Meeting held in relation to the merger at 9:00 a.m. Eastern Time on Thursday, November 7, 2024 at the Company’s offices in London, shareholders approved the Company’s issuance o ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number 001-36288 Akari Therapeutics, Plc (Exact name of Registrant as specified in its Charter) England and Wales ...

Exhibit 99.1 Akari Therapeutics Reports Second Quarter 2024 Financial Results and Recent Highlights Samir R. Patel, M.D. Appointed Interim CEO; Interim CEO Employment Contract Demonstrates Alignment with Shareholders Plan for Prioritization of Peak Bio's ADC Cancer Therapeutic Platform Technology and Akari's PAS-nomacopan for Geographic Atrophy Existing Investors Support the Company with Issuance of $1 Million in Unsecured Convertible Notes Secured $7.6 Million in Upsized Financing Round Receives Positive a ...

Samir R. Patel, M.D. Appointed Interim CEO; Interim CEO Employment Contract Demonstrates Alignment with Shareholders Plan for Prioritization of Peak Bio’s ADC Cancer Therapeutic Platform Technology and Akari’s PAS-nomacopan for Geographic Atrophy Existing Investors Support the Company with Issuance of $1 Million in Unsecured Convertible Notes Secured $7.6 Million in Upsized Financing Round Receives Positive and Constructive Pre-IND Feedback from US FDA for PAS-nomacopan in Treatment of Geographic Atrophy ...

BOSTON and LONDON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics announced today that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari’s final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA). PAS-nomacopan is a long-acting bispecific inhibitor of C ...

BOSTON and LONDON, June 04, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics Plc (NASDAQ:AKTX), an innovative biotechnology company advancing therapies for autoimmune and inflammatory diseases, today announced the successful initial closing of a private placement financing round. This transaction is expected to raise an aggregate of approximately $7.6 million in gross proceeds from both new and existing investors. "We are pleased to announce this financing for Akari Therapeutics," said Samir R. Patel, MD, Interi ...